Evidence mapPaperPMID 41316185Full record

Trial reportBMC endocrine disorders2025

Effect of empagliflozin on liver fibrosis and steatosis in patients with type 2 diabetes and non-alcoholic fatty liver disease: a randomized clinical trial.

Azam Erfanifar, Shahriar Nikpour, Zahra Davoudi, Pardis Jolfaei, Hossein Toreyhi, Seyedeh Naghmeh Mostafavi Nasab

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in BMC endocrine disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Azam ErfanifarDepartment of Endocrinology, Research Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Shahriar NikpourResearch Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, P.O. Box 19395-4763, Tehran, Islamic Republic of Iran.
Zahra DavoudiDepartment of Endocrinology, Research Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Pardis JolfaeiStudent Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hossein Toreyhi *Gastroenterology and Liver Diseases Research Center, Shahid Beheshti University of Medical Sciences, P.O. Box 19395-4763, Tehran, Iran. Hoseinto@gmail.com.
Seyedeh Naghmeh Mostafavi Nasab *Research Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, P.O. Box 19395-4763, Tehran, Islamic Republic of Iran. mostafavinasab@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimMetabolic dysfunction-associated steatotic (MASLD) is a common complication in diabetic patients that can lead to fibrosis and severe liver complications. This study aimed to investigate the effect of empagliflozin on liver markers and fibrosis in diabetic patients with NAFLD.

methodsThis was a single-center, randomized, controlled, phase II clinical trial including 119 patients with type 2 diabetes and MASLD. Patients were randomized to receive either empagliflozin (10 mg or 25 mg daily) or standard care for 6 months. Liver enzymes, imaging scores (MRI and ultrasound), and fibrosis indices (FIB-4 and NFS) were assessed at baseline and at study completion. Statistical analyses included between- and within-group comparisons, adjusted models for baseline imbalances and age.

resultsEmpagliflozin significantly reduced liver enzymes compared with controls (ALT − 41.2 vs. −4.6 IU/L; AST − 18.4 vs. −3.3 IU/L; GGT − 25.5 vs. −2.2 IU/L; all p < 0.001). The FIB-4 index decreased in the intervention group (1.20→1.06, p < 0.001) but not in controls (1.42→1.42, p = 0.233). The NAFLD fibrosis score showed no significant change. Imaging confirmed greater improvement in the empagliflozin group, with 94% showing grade 1 or lower steatosis on ultrasound and 100% achieving grade 0 on MRI (p < 0.001 for both). Importantly, complementary analyses (ANCOVA and mixed models) demonstrated that these improvements remained significant after adjustment for age and baseline values.

conclusionEmpagliflozin significantly improved liver enzymes, imaging scores, and FIB-4 in patients with T2DM and MASLD. These findings support its potential as a therapeutic option in metabolic liver disease and highlight the need for longer, multicenter trials to confirm sustained benefits and to explore combination strategies with other agents. CLINICAL

trial registrationThis study is related to a previously registered clinical trial conducted at Loqman-e-Hakim Hospital. The clinical trial was registered with the Iranian Registry of Clinical Trials under the number IRCT20210811052150N1.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesLiver CirrhosisNon-alcoholic Fatty Liver DiseaseSodium-Glucose Transporter 2 InhibitorsAdultBiomarkersFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisBenzhydryl CompoundsBiomarkersempagliflozinGlucosidesSodium-Glucose Transporter 2 InhibitorsEmpagliflozinLiver enzymesLiver fibrosisNon-alcoholic fatty liver diseaseType 2 diabetes

Identifiers

PMID41316185
PMCPMC12664258

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.